[Federal Register Volume 62, Number 157 (Thursday, August 14, 1997)]
[Notices]
[Pages 43539-43540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 43540]]
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on September 18 and 19,
1997, 8 a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms II and III, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Jannette O'Neill-Gonzalez, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12542. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On September 18, 1997, the committee will discuss: (1) New
drug application (NDA) 20-817, RivizorTM Tablets (vorozole,
Janssen Research Foundation), indicated for ``the treatment of advanced
breast cancer in postmenopausal women (natural or artificially-induced
menopause) with disease progression following antiestrogen therapy'';
and (2) NDA Supplement 20-451/S002, Photofrin (porfimer
sodium, QLT Photo Therapeutics Inc.), indicated for: ``a) reduction of
obstruction and palliation of symptoms in patients with completely or
partially obstructing endobronchial nonsmall cell lung cancer (NSCLC),
and b) treatment of endobronchial carcinoma in situ or microinvasive
NSCLC in patients for whom surgery and radiotherapy are not
indicated.'' On September 19, 1997, the committee will discuss: (1) NDA
20-826, Paxene (paclitaxel, Baker-Norton Pharmaceuticals,
Inc.), ``indicated after failure of first line or subsequent systemic
chemotherapy for the treatment of advanced AIDS-related Kaposi's
Sarcoma''; and (2) NDA Supplement 16-295/S029, Droxia
(hydroxyurea, Bristol-Myers Squibb), ``indicated in the treatment of
sickle cell anemia in adult patients to prevent painful crises and to
reduce the need for blood transfusions.''
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by September 4,
1997. Oral presentations from the public will be scheduled between
approximately 8:05 a.m. and 9:05 a.m. on both days. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 4,
1997, and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 7, 1997.
William B. Schultz,
Acting Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-21572 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F
